D-0516-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2025
- Initiation Date
- June 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,448 bottles
Product Description
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
Reason for Recall
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Distribution Pattern
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Code Information
Lot # AD42648, Exp 02/28/2026